MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; HYPODERMIC SYRINGE

Catalog Number 300629

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported with the use of the bd plastipak¿ luer-lok¿ syringe there was an issue with difficult plunger movement.It was stated ¿the customer is working on the pharmacy (cytostatic department) where they regularly draw up a lot of medicine in our bd plastipak.They complain that the stamp is very tight on all the mentioned syringes sizes (3, 5, 10, 20, 30 ml).They are aware about pressing the syringe plunger all the way down to make the syringe plunger slide more easily before use, but they still think it is very hard to work with.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: two unused samples were received for evaluation by our quality engineer.Upon visual inspection of the two samples received, no damages or molding defects could be observed.A device history record review of lot 1802278 did not reveal any anomalies during the production of the provided lot number that could have contributed to the reported defect.During the manufacturing process, break out force, sustaining force and silicone content tests are performed to ensure all products are within specification.Break out force, sustaining force, and silicone content tests were performed on ten retained samples of the same lot; the results were within specifications.As no issues were identified to support manufacturing related errors for the reported defect, a definite cause for this incident could not be determined.Based in severity and occurrence not formal capa is required according to internal procedure.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7588158
• MDR Text Key: 111161339
• Report Number: 3003152976-2018-00238
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 300629
• Device Lot Number: 1802278
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other